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New hope for ROS1+ cancer patients: expanded access to zidesamtinib

NCT ID NCT06797362

Disease control Sponsor: Nuvalent Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access This study
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 26, 2026 · Updated 3 times

Summary

This expanded access program provides the investigational drug zidesamtinib (NVL-520) to adults with advanced ROS1-positive non-small cell lung cancer or other solid tumors who have no satisfactory treatment options and cannot join a clinical trial. Participants must have received at least one prior ROS1-targeted therapy. The goal is to offer a potential treatment when no alternatives exist.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
zidesamtinib (NVL-520), an oral tablet
What this could lead to
If it works, this could provide a treatment option for people with advanced ROS1-positive cancers who have run out of standard therapies.
What could go wrong
This is an expanded access program, not a formal trial, so effectiveness and safety are not fully established. It may not work for everyone and could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥18 years. 2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC or other solid tumor with documented ROS1 rearrangement. 3. Previously received at least 1 prior ROS1 TKI, with no comparable or satisfactory alternative treatment options, in the opinion of the treating physician. 4. Enrollment in a clinical trial of zidesamtinib is not possible. 5. Adequate organ function and bone marrow reserve. Exclusion Criteria: 1. Prior receipt of zidesamtinib. 2. Previous surgery, chemotherapy, radiotherapy or other anti-cancer therapy or participation in other studies within timeframe indicated in the protocol. 3. Ongoing anti-cancer therapy. 4. Eligible for ongoing clinical trial with zidesamtinib

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer ROS1-positive non-small cell lung cancer (NSCLC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    30 sites in 10 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AUSL della Romagna - Ravenna

    AVAILABLE

    Ravenna, 48121, Italy

  • Antoni van Leeuwenhoek Hospital

    AVAILABLE

    Amsterdam, 1006 BE, Netherlands

  • CHU de Nantes

    AVAILABLE

    Nantes, Pays de la Loire Region, 44800, France

  • Centre Leon Berard

    AVAILABLE

    Lyon, Auvergne-Rhône-Alpes, 69008, France

  • Chris O'Brien Lifehouse

    AVAILABLE

    Camperdown, New South Wales, 2050, Australia

  • Chung Shan Medical University

    AVAILABLE

    Taichung, 402306, Taiwan

  • Cross Cancer Institute

    AVAILABLE

    Edmonton, Alberta, T6G 1Z2, Canada

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    AVAILABLE

    Milan, 20133, Italy

  • GCS IUCT Oncopole

    AVAILABLE

    Toulouse, Occitanie, 31059, France

  • Gregorio Marañón General University Hospital

    AVAILABLE

    Madrid, 28007, Spain

  • Hospital Univ Doce de Octubre

    AVAILABLE

    Madrid, 28041, Spain

  • Hospital Universitario Vall d'Hebron

    AVAILABLE

    Barcelona, 08035, Spain

  • IRCCS Istituto Oncologico Veneto

    AVAILABLE

    Padova, 35128, Italy

  • IRCCS Istituto Tumori Giovanni Paolo II

    AVAILABLE

    Bari, 70124, Italy

  • Institut Gustave Roussy

    AVAILABLE

    Villejuif, Île-de-France Region, 94800, France

  • Istituto Nazionale Tumori "Regina Elena

    AVAILABLE

    Roma, 00144, Italy

  • L'Istituto Europeo di Oncologia S.r.l.

    AVAILABLE

    Milan, 20141, Italy

  • National Cancer Centre Singapore

    AVAILABLE

    Singapore, 168583, Singapore

  • National Cheng Kung University Hospital

    AVAILABLE

    Tainan, 70403, Taiwan

  • National Taiwan University Hospital

    AVAILABLE

    Taipei, 100229, Taiwan

  • National University Hospital Singapore

    AVAILABLE

    Singapore, 119074, Singapore

  • Netherlands Cancer Institute: NKI

    AVAILABLE

    Amsterdam, 1066 CX, Netherlands

  • Peter MacCallum Cancer Centre

    AVAILABLE

    Melbourne, Victoria, 3000, Australia

  • Princess Margaret Hospital

    AVAILABLE

    Toronto, Ontario, M5G 2M9, Canada

  • The Christie Hospital

    AVAILABLE

    Manchester, M20 4BX, United Kingdom

  • The Royal Marsden Hospital

    AVAILABLE

    Sutton, Surrey, SM2 5PT, United Kingdom

  • The Royal Marsden Hospital

    AVAILABLE

    London, SM2 5PT, United Kingdom

  • UZLeuven

    AVAILABLE

    Leuven, 3000, Belgium

  • University Medical Center Groningen

    AVAILABLE

    Groningen, 9713 GZ, Netherlands

  • Uomi Cancer Center-Clinica Tres Torres

    AVAILABLE

    Barcelona, 08017, Spain

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